Oracit

Name: Oracit

What is Oracit (citric acid and sodium citrate)?

Citric acid and sodium citrate are both alkalinizing agents that make the urine less acidic.

The combination of citric acid and sodium citrate is used to prevent gout or kidney stones, or metabolic acidosis in people with kidney problems.

Citric acid and sodium citrate may also be used for other purposes not listed in this medication guide.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 2 hours late in taking your medicine, wait until your next regularly scheduled time to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

How do I store and/or throw out Oracit?

  • Store at room temperature. Do not freeze.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Action

Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete.

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

NDC 46287-014-01
500 mL

Oracit®
ORAL CITRATE (SHOHL'S) SOLUTION

CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL;
Citric Acid USP 640 mg/5 mL; Methylparaben NF;
Propylparaben NF; Alcohol USP 0.25%.

USUAL DOSAGE: See package insert.

Dispense in a well-closed container.

Store at 20°-25°C (68°-77°F); excursions permitted
to 15°-30°C (59°-86°F). [See USP Controlled Room
Temperature].

Rx Only

LOT:
EXP:

CMP
PHARMA
Farmville, NC 27828

Oracit 
citric acid and sodium citrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:46287-014
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 640 mg  in 5 mL
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 490 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
METHYLPARABEN  
PROPYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:46287-014-01 500 mL in 1 BOTTLE
2 NDC:46287-014-30 10 BOTTLE, UNIT-DOSE in 1 CARTON
2 30 mL in 1 BOTTLE, UNIT-DOSE
3 NDC:46287-014-15 10 BOTTLE, UNIT-DOSE in 1 CARTON
3 15 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/15/1984
Labeler - CMP Pharma, Inc. (005224175)
Establishment
Name Address ID/FEI Operations
CMP Pharma, Inc. 005224175 MANUFACTURE(46287-014)
Revised: 06/2016   CMP Pharma, Inc.
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